510(k) Report

Devices descending from K093301

6 later devices reach Turbohawk Peripheral Plaque Excision System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc.201141
+1K103618Turbohawk Peropheral Plaque Excision SystemEv3, Inc.20114—
+2K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMedtronic Vascular, Inc.20171—
+2K141801Hawkone Directional Atherectomy SystemCovidien, LLC20141—
+3K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc.20210Class I
+3K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc.20160Class I